Kornimate/medical-research-clean huggingface dataset:
follow-up study on the antibody response to hepatitis b, acellular pertussis toxin and inactivated poliovirus antigens 1 month after the 4th hexavac® vaccination in healthy children, who participated in neisvac-c study 216

Conditions: Meningococcal Meninigitis, Serogroup C

Summary: the primary aim of the study is to show that the antibody response to hepatitis b, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with hexavac® is not influenced by the concomitant administration of neisvac-c.


Eligibility criteria:
inclusion criteria: study subjects who completed study 216 will be eligible for participation in this study if: * they received all 3 vaccinations with hexavac during study 216 and the 4th hexavac vaccination outside the study * the subject's parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child's study participation; * a blood draw was performed after the 3rd vaccination during study 216. exclusion criteria: study subjects will be excluded from participation in this study if: * they have received any vaccination containing hepatitis b, poliovirus or acellular pertussis toxin antigens other than hexavac * they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th hexavac vaccination until study entry * they have received another vaccine during the period from 28 days prior to the 4th hexavac vaccination until study entry * they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216 * they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216 * they have received systemic corticosteroids during the period from 28 days prior to the 4th hexavac vaccination until study entry.

Keywords: meningococcal vaccine meningococcal meningitis, serogroup c neisseria meningitidis
outcomes of smoker and drinker with esophageal squamous cell carcinoma after esophagectomy

Conditions: Outcomes of Smoker and Drinker After Esophagectomy

Summary: our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (os) after undergoing esophagectomy. furthermore, our findings indicate that there was no statistically significant difference in os between patients with a history of both smoking and drinking, and those who only smoked or drank


Eligibility criteria:
inclusion criteria: patients with esophageal cancer exclusion criteria: (1) pathology confirmed a non-squamous cell carcinoma, (2) the tumor was located outside of the thoracic region, (3) r1/r2 resection was performed indicating incomplete tumor removal, (4) evidence of distant tumor metastasis was observed, (5) they underwent preoperative neoadjuvant therapy, (6) ptis/t1a stage (7) missing data.

Keywords: survival esophgeal cancer smoker drinker
comparison of difference hydrodissection for cts

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. rather than other progressive disease, cts is characterized by remission and recurrence. the hydrodissection could decrease the entrapment of nerve to restore blood supply. despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. the investigators design a randomized, double-blind, controlled trial to assess the effect of different method of ultrasound-guided hydrodissection in patients with cts.

after obtaining written informed consent, patients with bilateral cts will been randomized into intervention and control group. participants in short-axis group received one-dose ultrasound-guided hydrodissection with short-axis approach and long-axis group received one-dose ultrasound-guided injection with long-axis approach. no additional treatment after injection through the study period. the primary outcome is boston carpal tunnel syndrome questionnaire (bctq) and secondary outcomes include visual analog scale (vas), cross-sectional area (csa) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. the evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

Eligibility criteria:
inclusion criteria: * age between 20-80 year-old. * diagnosis was confirmed using an electrophysiological study exclusion criteria: * cancer * coagulopathy * pregnancy * inflammation status * cervical radiculopathy * polyneuropathy, brachial plexopathy * thoracic outlet syndrome * previously undergone wrist surgery or steroid injection for cts

Keywords: hydrodissection short-axis long-axis
older men's decision making about active surveillance for prostate cancer - aim 3: decision aid efficacy testing

Conditions: Prostate Cancer

Summary: this protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer make decisions with their health care providers about if and when to de-escalate surveillance testing. the project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. for these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.

primary objective: the overall goal of this protocol is to test initial efficacy of three versions of an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance. a pre-post design was selected to provide initial efficacy data of the different versions of the shared decision-making intervention. thereby, providing preliminary data in preparation for a follow-up comparative study.

Eligibility criteria:
inclusion criteria: patients: 1. males aged 65 or older 2. diagnosis of localized prostate cancer 3. have not received curative intent treatment for their prostate cancer 4. fluent in english care partners/caregivers: 1. aged 18 or older 2. fluent in english 3. involved with the care of an eligible patient (i.e. partner, close friend, family member, companion) exclusion criteria: patients 1. currently receiving treatment for another cancer (primary or recurrence) care partners/caregivers 1. none
effect of administration of itraconazole on the pharmacokinetics of s-309309 in healthy participants

Conditions: Obesity; Healthy Volunteers

Summary: the primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (pk) profile of s-309309; and the pk of s-309309 following administration of s-309309 alone and co-administration with itraconazole


Eligibility criteria:
key inclusion criteria: * participants who are considered to be medically healthy as determined by the investigator * participants whose body mass index (bmi) is within the range of ≥ 18.5 to ≤ 30.0 kg/m\^2 * contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * participants who understand the study procedures and agree to participate by providing written informed consent * participants who are willing and able to comply with all study procedures and restrictions key exclusion criteria: * participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug. * participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema. * participants who have a history of gastrointestinal surgery including, but not limited to, cholecystectomy, gastric resection, and/or intestinal resection that may result in a clinically significant abnormality in gastrointestinal function (except for an appendectomy). participants can be considered by the investigator (or sub-investigator) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations. * participants who are considered inappropriate for participation in the study for any reason by the investigator (or sub-investigator). note: other protocol defined inclusion/exclusion criteria may apply.
a study of oral clofarabine in adult patients with myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndromes

Summary: this study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.


Eligibility criteria:
inclusion criteria: * provide signed, written informed consent. * be at least 18 years old. * have a pathologically confirmed mds and score according to the ipss at study entry. pathologic confirmation is the responsibility of the investigator. * have been treated previously for mds as follow: a.patients must have had at least 1, but no more than 2, prior treatment regimens; b.patients must not have refractory (i.e., disease progression or no evidence of response while on treatment) to more than 1 prior treatment regimen. * have eastern cooperative oncology group (ecog) performance status of 0-2 * be able to comply with study procedures and follow-up examinations. * have adequate hepatic and renal function. * be non-fertile or agree to use birth control during the study through the end of the last treatment visit and at least 90 days after. exclusion criteria: * have had a readjustment of dose and/or schedule of erythropoietin, granulocyte colony stimulating factor(g-csf) or other growth factors within 8 weeks prior to the first dose of oral clofarabine. * have had any other chemotherapy or any investigational therapy for mds within 4 weeks of the first dose of oral clofarabine. * have not recovered to ≤ grade 2 in severity of any drug-related non-hematologic toxicity prior to the first dose of oral clofarabine. * have an uncontrolled systemic fungal, bacterial, viral or other infection. have a history of serious disease involving the heart. * have a clinically significant cardiac assessment at screening or a known family history qt prolongation. * currently uses a medication known to prolong the qt interval. * have had any prior treatment with clofarabine (iv or oral). * have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years after completing curative intent therapy except for the following: a. patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment or the condition has been completed. b. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed. * have prior positive test for the human immunodeficiency virus (hiv). * have gastrointestinal disease or prior surgery, which may affect the ability of the patient to absorb oral clofarabine. * is currently participating in another concurrent investigational protocol that is not restricted to data and/or sample collection for patient demographic and/or disease purposes.

Keywords: oral clofarabine, relapsed/refractory mds, myelodysplastic
post evar endoleak detection : model-based iterative reconstruction (mbir) vs adaptive statistical iterative reconstruction (asir) cta; a prospective study

Conditions: Post EVAR Endoleak Detection

Summary: the purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient with evar comparing adaptive statistical iterative reconstruction (asir) cta and model-based iterative reconstruction (mbir- veo tm).

background: the aortic aneurysm is a common and serious disease share its complications (rupture ) , often fatal. it is recognized that pass a certain diameter surgical or endovascular treatment reduces mortality by avoiding treatment in extreme provider of high morbidity and mortality emergency. endovascular anevrysm repair (evar) treatment has proven effective but unfortunately this treatment presents complications ( endoleak ) should be sought systematically by repeated checks ct . the irradiation in these patients is a major problem with repeated exposure radiation. the follow up of these patients requires repeated ct because endoleaks can be delayed. iterative reconstruction of previous generation have reduced the dose , we dispose the last model-based iterative reconstruction (" veo " ) for a further reduction of patient dose . this technique has not yet been evaluated in the detection of endoleaks. the purpose of the study is to compare conventional cta (asir50) ( gold standard now) with model-based iterative reconstruction (mbir- veo tm) in the detection ( and classification ) of endoleaks in patients traited by evar. all patient admited in radiology to follow up his evar is included in the study and receive both ct: adaptive statistical iterative reconstruction (asir) cta and model-based iterative reconstruction (mbir- veo tm) and the result of thoses 2 ct are compared by 2 readers (blinded of the result) the bmi , other complications, the dlp , dose reduction and quality of the examination is noted .

Eligibility criteria:
inclusion criteria: * informed and a written consent * all patients consulting to follow up his evar * 18-90 years * french exclusion criteria: * pregnant * juvenile patients * patient who refusal the study * ci of contrast iodine injection : ci of ultravist * llergy * renal failure creatinemy \<30 ml/min

Keywords: endovascular aneurysm repair evar endoleak/diagnosis veotm model-based iterative reconstruction (mbir) adaptive statistical iterative reconstruction (asir) aortic aneurysm low dose prospective cta
targeting right ventricle in pulmonary hypertension gilead

Conditions: Pulmonary Hypertension

Summary: this study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension therapies but with right ventricular dysfunction (rvef \<45%) will improve their health by improving right ventricular (rv) function.


Eligibility criteria:
inclusion criteria: * symptomatic pulmonary hypertension based on one of the following criteria: * idiopathic pulmonary arterial hypertension * familial pulmonary arterial hypertension * pulmonary hypertension associated with connective tissue disease * chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate * simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension * group 3 patients who have a component of pulmonary arterial hypertension \*pulmonary hypertension caused by conditions affect the veins and small vessels of the lungs * sickle cell disease * group 5 pulmonary hypertension such as polycythemia vera * essential thrombocythemia * sarcoidosis * vasculitis * metabolic disorder * world health organization functional class ii, iii, or iv * mean pulmonary artery pressure \>25 mmhg at rest * pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmhg * pulmonary vascular resistance \> 3 mmhg/l/min * right ventricle ejection fraction \< 45% * 6-minute walk test distance \> 50 meters exclusion criteria: * previous treatment with or prior sensitivity to ranolazine * any family history of corrected qt interval prolongation, congenital long qt syndrome, or receiving drugs that prolong the corrected qt interval * parenchymal lung disease showing total lung capacity \< 50% of predicted or forced expiratory volume at one second/forced vital capacity \< 50% * portal hypertension associated with chronic liver disease * left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, any left ventricle cardiomyopathy, left ventricular systolic dysfunction defined as an ejection fraction \< 50%, symptomatic coronary artery disease * uncontrolled systemic hypertension * implantable cardioverter-defibrillator, pacemaker, hazardous metallic implants or any other contraindication to mri.

Keywords: pulmonary hypertension right ventricular function ranolazine
iron status in autism spectrum disorders

Conditions: Anemia, Iron Deficiency

Summary: to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group


Eligibility criteria:
inclusion criteria: * children who are diagnosed with autism spectrum disorder according to dsm -v * not having infection inflammatory conditions chronic physical illness * children who are not receiving iron supplementation exclusion criteria: * age below 2 years and above 12 years * having an infection or inflammatory conditions chronic physical illness * receiving iron supplementation
improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection:a phase i-ii clinical trial

Conditions: Liver Failure; Cirrhosis

Summary: the methods for separation of mesenchymal stem cell were established in 2001. these cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. in this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. the investigators determine the effects of injected cells in reestablishment of liver function.


Eligibility criteria:
inclusion criteria: * meld score of at least 10 * patent portal vein on color doppler examination of the liver * normal alpha-feto protein serum levels * age more than 18 * filling inform consent by patients and first degree family members exclusion criteria: * any evidence of hepatocellular carcinoma on liver ultrasound studies * patients want to exclude from study

Keywords: mesenchymal stem cell end stage liver disease cirrhosis stem cell therapy
diabetes self-management with continuous glucose monitoring

Conditions: Type 1 Diabetes

Summary: the overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (cgm) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics. participants will: * visit the clinic twice with a 14-day interval * fill out a survey before the first and at the last visit * use cgm as usual and use smart insulin pens and an activity tracker * register food intake * answer two-three questions twice a day in redcap

a two-centre observational study conducted in denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using freestyle libre 2. upon recruitment, participants will complete a survey of 11 validated questionnaires, including t1-dds-28. for 14 days, participants will continue regular cgm use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor physical activity and sleep. participants will register food intake in the librelink app and respond to queries on quality of life twice daily through redcap. at the end of the study, participants will complete the t1-dds-28 and health literacy questionnaire. our primary objectives is to investigate the association between diabetes distress (assessed by type 1 diabetes distress scale (t1-dds-28)) and: 1. frequency of reading cgm data, 2. frequency of low glucose alarms, 3. frequency of high glucose alarms, 4. frequency of daily between-meal insulin corrections, 5. frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin, 6. frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and 7. sociodemographic and psychosocial characteristics of cgm users. our secondary objective is to investigate the association between glycaemic metrics and the variables described above. glycaemic metrics will be reported as cgm-metrics, including time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/l (70-180 mg/dl), per international consensus (attd, 2022)

Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years. 2. diagnosed with t1d over one year ago. 3. actively using freestyle libre 2 (\>80% sensor activity). 4. used freestyle libre 2 for over three months. 5. uses multiple daily insulin injections. 6. capable of providing written informed consent. 7. willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion. exclusion criteria: 1. history of allergic reactions to materials or adhesives used in cgm devices. 2. presence of severe cognitive or psychiatric conditions that could hinder the effective use of cgm or smart caps or pens - at the investigator's discretion. 3. current use of steroids unless part of a chronic therapy plan. 4. daily consumption of vitamin c ≥ 500 mg.

Keywords: continuous glucose monitoring self-management diabetes technology type 1 diabetes diabetes distress patient-reported outcomes